Main Content

Introduction

Research involving women who are or may become pregnant requires special attention from IRBs because of women's additional health concerns during pregnancy and because of the need to avoid unnecessary risk to the fetus.

IRBs must judge whether the mother's participation would pose any risk to the fetus or nursing infant. In some studies, IRBs may need to ensure that nonpregnant subjects are advised to avoid pregnancy or nursing for a time during or following the research. Furthermore, where appropriate, subjects should be advised to notify the investigator immediately should they become pregnant. In some instances there may be potential risk sufficient to justify requiring that pregnant women either be specifically excluded from the research or studied separately.

Points to Consider

For all studies, is there reason to exclude pregnant or lactating women? If so, how strict should the screening measures be?

For all studies involving pregnant women, have appropriate studies on animals and nonpregnant humans been conducted? Is any special monitoring of the informed consent process needed?

For studies directed toward maternal health, is the risk to the fetus the least possible consistent with the research objectives? Will the mother be adequately informed of the potential risk to the fetus and of alternative treatments and their risks and benefits?